Neuromaster G1 MEE200

K142624 · Nihon Kohden Corporation · GWF · Apr 24, 2015 · Neurology

Device Facts

• Record ID: K142624
• Device Name: Neuromaster G1 MEE200
• Applicant: Nihon Kohden Corporation
• Product Code: GWF · Neurology
• Decision Date: Apr 24, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1870
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Neuromaster G1 MEE 2000 Neural Function Measuring System is intended to monitor, record, and display the bioelectric signals produced by sensory and motor pathways in the operating room, critical care, and other areas where continuous monitoring is needed. The system measures and displays electric/auditory/visual evoked potential (EP), electroencephalography (EEG), and electromyography (EMG), skin temperature of distal portion of extremities, SpO2, and ETCO2 to provide health care professionals with information to help assess a patient's neurological status. The system is used as a nerve stimulator for surgical procedures and brain mapping during treatment of patients with seizure disorders and used for the intraoperative diagnosis of acute dysfunction in corticospinal axonal conduction brought about by mechanical trauma (traction, shearing, laceration, or compression) or vascular insufficiency. · EEG - The device may also measure and record the electrical activities of the patient's brain obtained by placing two or more electrodes on the head (EEG). · EP-Electrical/ Auditory/ Visual - Continuous and/or periodic measurements of evoked potential activities are displayed and stored. The device applies an electrical stimulus to a patient through commercially available skin electrodes for the purpose of measuring the evoked response. The photic stimulator is used to generate and display a shifting pattern or to apply a brief light stimulus to a patient's eye and the auditory stimulator produces a sound stimulus for use in evoked response measurements or electroencephalogram activation. · Free Run EMG - The Free Run EMG function identifies spontaneous EMG activity of nerves by continually displaying a live stream waveform of any mechanically induced myotome contractions. · CoMEP - Cortical stimulation techniques for cortical mapping are used at "Low Output" for placement of electrodes during surgical procedures and for brain mapping during treatment of patients with seizure disorders. · TcMEP - Transcranial electrical stimulation techniques for motor evoked potentials (TcMEP) are used at "TcMEP Output" for the intraoperative diagnosis of acute dysfunction in corticospinal axonal conduction brought about by mechanical trauma (traction, shearing, laceration, or compression) or vascular insufficiency. · Nerve conduction study - The device is intended to measure and display nerve conduction time by applying a stimulus to a patient's peripheral nerve. This device includes the stimulator and the electronic processing equipment for measuring and displaying the nerve conduction time. · SpO2 - When the SpO2 adapter and toe probe for SpO2 measurement are used, oxygen saturation information is automatically measured and displayed. · EtCO2 - When the CO2 adapter and sensor for EtCO2 measurement are used, end-tidal carbon dioxide of respiratory gas information is automatically measured and displayed. · Skin temperature - When the skin temperature measurement is used, skin temperature information is automatically measured and displayed. · Remote reader - The remote reader function provides real time remote access to the system for a monitoring physician outside of the operating room. The system is intended for use by medical personnel within a hospital, laboratory, clinic or nursing home setting or outside of a medical facility under direct supervision of a medical professional. The system is available for use on any patient as determined by the medical professional including adults and children of all ages.

Device Story

System monitors/records bioelectric signals (EP, EEG, EMG) and vital signs (SpO2, ETCO2, skin temp) intraoperatively or in critical care. Inputs: electrical/auditory/visual stimuli via electrodes/probes; patient bioelectric signals. Outputs: live waveforms, trend graphs, and event annotations on a display. Used by medical personnel (physicians, technicians) in hospitals/clinics. Remote reader allows physician access outside OR. Device aids neurological status assessment, brain mapping, and intraoperative diagnosis of corticospinal dysfunction. Benefits: continuous monitoring of neural pathways during surgery/critical care to detect acute dysfunction.

Clinical Evidence

Bench testing only. No clinical data provided. Verification and validation included electrical safety, electromagnetic compatibility, software V&V, operational performance, and usability testing.

Technological Characteristics

Computer-based system with main unit, amp unit, breakout boxes, and stimulation pods. Measures EP, EEG, EMG, SpO2, ETCO2, skin temp. Connectivity: 10/100/1000 Mb/s Ethernet. Software-based signal processing. Complies with IEC 60601-1 3rd edition. Non-sterile, non-patient contacting (except accessories).

Indications for Use

Indicated for monitoring, recording, and displaying bioelectric signals (EP, EEG, EMG) and physiological parameters (SpO2, ETCO2, skin temperature) in OR, critical care, or clinical settings. Used for nerve stimulation, brain mapping in seizure disorders, and intraoperative diagnosis of corticospinal axonal conduction dysfunction due to trauma or vascular insufficiency. Available for all patient populations (adults and children).

Regulatory Classification

Identification

An evoked response electrical stimulator is a device used to apply an electrical stimulus to a patient by means of skin electrodes for the purpose of measuring the evoked response.

Predicate Devices

• Neuromaster MEE1000 Neural Function Measuring System (K051178)
• Cadwell Cascade (K962455)
• XLTEK (K040358)
• Eclipse Neurological Workstation (K050798)
• Subdural Electrodes (K053363)
• SEN-4100A Electric Stimulator (K071969)
• Nerve Integrity Monitor 3.0 (K083124)
• MS-120BK Electrical Stimulator (K110410)
• C2 Nerve Monitor System (K111647)
• NVM5 System (K112718)
• MEB-2300A (K120397)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, one behind the other, creating a sense of depth and unity. The profiles are rendered in a simple, abstract manner.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

April 24, 2015

Nihon Kohden Corporation % Natalie Kennel Regulatory Affairs Consultant NJK & Associates Inc. 13721 Via Tres Vista San Diego, California 92129

Re: K142624

> Trade/Device Name: Neuromaster G1 Mee2000 Regulation Number: 21 CFR 882.1870 Regulation Name: Evoked Response Electrical Stimulator Regulatory Class: Class II Product Code: GWF, IKN, ETN, GWO, JXE, GZO, GWF, and GWJ Dated: March 20, 2015 Received: March 25, 2015

Dear Ms. Kennel,

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device

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related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Carlos L. Pena -S 同公

Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### DEPARTMENT OF HEALTH AND HUMAN SERVICES. Food and Drug Administration

# Indications for Use

510(k) Number (if known) K142624 Page 1 of 3

#### Device Name

Neuromaster G1 MEE2000 Neural Function Measuring System

### Indications for Use (Describe)

The Neuromaster G1 MEE 2000 Neural Function Measuring System is intended to monitor, record, and display the bioelectric signals produced by sensory and motor pathways in the operating room, critical care, and other areas where continuous monitoring is needed. The system measures and displays electric/auditory/visual evoked potential (EP), electroencephalography (EEG), and electromyography (EMG), skin temperature of distal portion of extremities, SpO2, and ETCO2 to provide health care professionals with information to help assess a patient's neurological status. The system is used as a nerve stimulator for surgical procedures and brain mapping during treatment of patients with seizure disorders and used for the intraoperative diagnosis of acute dysfunction in corticospinal axonal conduction brought about by mechanical trauma (traction, shearing, laceration, or compression) or vascular insufficiency.

· EEG - The device may also measure and record the electrical activities of the patient's brain obtained by placing two or more electrodes on the head (EEG).

· EP-Electrical/ Auditory/ Visual - Continuous and/or periodic measurements of evoked potential activities are displayed and stored. The device applies an electrical stimulus to a patient through commercially available skin electrodes for the purpose of measuring the evoked response. The photic stimulator is used to generate and display a shifting pattern or to apply a brief light stimulus to a patient's eye and the auditory stimulator produces a sound stimulus for use in evoked response measurements or electroencephalogram activation.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

## PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

### FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

This section applies only to requirements of the Paperwork Reduction Act of 1995.

## *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

510(k) Number (if known) K142624 page 2 of 3

#### Device Name

Neuromaster G1 MEE2000 Neural Function Measuring System

Indications for Use (Describe)

· Free Run EMG - The Free Run EMG function identifies spontaneous EMG activity of nerves by continually displaying a live stream waveform of any mechanically induced myotome contractions.

· CoMEP - Cortical stimulation techniques for cortical mapping are used at "Low Output" for placement of electrodes during surgical procedures and for brain mapping during treatment of patients with seizure disorders.

· TcMEP - Transcranial electrical stimulation techniques for motor evoked potentials (TcMEP) are used at "TcMEP Output" for the intraoperative diagnosis of acute dysfunction in corticospinal axonal conduction brought about by mechanical trauma (traction, shearing, laceration, or compression) or vascular insufficiency."

· Nerve conduction study - The device is intended to measure and display nerve conduction time by applying a stimulus to a patient's peripheral nerve. This device includes the stimulator and the electronic processing equipment for measuring and displaying the nerve conduction time.

· SpO2 - When the SpO2 adapter and toe probe for SpO2 measurement are used, oxygen saturation information is automatically measured and displayed.

· EtCO2 - When the CO2 adapter and sensor for EtCO2 measurement are used, end-tidal carbon dioxide of respiratory gas information is automatically measured and displayed.

· Skin temperature - When the skin temperature measurement is used, skin temperature information is automatically measured and displayed.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

## PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

## FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

This section applies only to requirements of the Paperwork Reduction Act of 1995.

### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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#### DEPARTMENT OF HEALTH AND HUMAN SERVIGES Food and Drug Administration

# Indications for Use

510(k) Number (if known) K142624 page 3 of 3

#### Device Name

Neuromaster G1 MEE2000 Neural Function Measuring System

Indications for Use (Describe)

· Remote reader - The remote reader function provides real time remote access to the system for a monitoring physician outside of the operating room.

The system is intended for use by medical personnel within a hospital, laboratory, clinic or nursing home setting or outside of a medical facility under direct supervision of a medical professional.

The system is available for use on any patient as determined by the medical professional including adults and children of all ages.

### Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

## PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

## FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

This section applies only to requirements of the Paperwork Reduction Act of 1995.

## *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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Image /page/5/Picture/0 description: The image shows the logo for NIHON KOHDEN, a medical device company. The logo consists of a blue abstract symbol on the left and the company name "NIHON KOHDEN" in blue capital letters on the right. Below the logo, the text "510(k) Summary" is written in a bold, serif font.

| Sponsor: | Nihon Kohden Corporation<br>1-31-4 Nishiochiai, Shinjuku-Ku<br>Tokyo, Japan 161-8560 |
|------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Initial Importer | Nihon Kohden America<br>15353 Barranca Parkway<br>Irvine, CA |
| Contact Person: | Ms. Natalie J. Kennel<br>Consultant<br>NJK & Associates, Inc.<br>13721 Via Tres Vista<br>San Diego, CA 92129 USA<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |

Date Prepared: April 22, 2015

# DEVICE INFORMATION

| Proprietary Name: | Neuromaster G1 MEE2000 System |
|---------------------------------------------|----------------------------------|
| Common Name: | Neural Function Measuring System |
| Classification: | Class II (Performance Standards) |
| Device Product Code & Classification Panel: | |
| Panel: Neurology | |
| 21 CFR 890.1375 product code IKN | |
| 21 CFR 874.1820 product code ETN | |
| 21 CFR 882.1400 product code GWQ | |
| 21 CFR 882.1550 product code JXE | |
| 21 CFR 882.1540 product code GZO | |
| 21 CFR 882.1870 product code GWF | |
| 21 CFR 882.1890 product code GWJ | |

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Predicate Devices:

The predicate devices are listed in Table 1. The main predicate device is the Neuromaster MEE1000 System and the other two are additional reference predicates. None of the predicates have been subject to design recalls.

| 510(k) | Product | 510(k) Holder |
|----------------------|---------------------------------------------------------|----------------------------------------------------|
| K051178 | Neuromaster MEE1000 Neural Function<br>Measuring System | Nihon Kohden America, Inc |
| K962455 | Cadwell Cascade | Cadwell Laboratories |
| K040358 | XLTEK | Excel Tech LTD |
| K050798 &<br>K061173 | Eclipse Neurological Workstation | Formerly Axon Systems, Inc. Now<br>Medtronic Xomed |
| K053363<br>(K850342) | Subdural Electrodes | AD-Tech |
| K071969 | SEN-4100A Electric Stimulator | Nihon Kohden Corporation |
| K083124 | Nerve Integrity Monitor 3.0 | Medtronic Xomed |
| K110410 | MS-120BK Electrical Stimulator | Nihon Kohden America, Inc. |
| K111647 | C2 Nerve Monitor System | Inomed |
| K112718 | NVM5 System | NuVasive |
| K120397 | MEB-2300A | Nihon Kohden America, Inc. |

Table 1 Table of Predicates

# Product Description:

The Neuromaster G1 MEE2000 Neural Function Measuring System is a compact and multi-functional system for continuous monitoring of brain and neural pathways intraoperatively and in critical care areas. The system measures and displays electric/auditory/visual evoked potential (EP), electroencephalography (EEG), and electromyography (EMG), skin temperature of distal portion of the extremities, SpO2 and ETCO2. The system also measures and displays nerve conduction time by applying a stimulus to a patient's peripheral nerve. The system includes the stimulator and the electronic processing equipment for measuring and displaying the nerve conduction time.

The system uses electrical stimulus, visual stimulus, or sound stimulus in evoked responses measurements (EP). Continuous and/or periodic measurements of evoked potential activities are displayed and stored. The system applies an electrical stimulus to a patient through skin electrodes for the purpose of measuring the evoked response. The photic stimulator is used to generate and display a shifting light pattern or to apply a brief light stimulus for use in evoked response measurements or electroencephalogram activation. The system may measure and record the electrical activities of the patient's brain obtained by placing two or more electrodes on the head (EEG).

The system can be used as a nerve stimulator for surgical procedures and brain mapping during treatment of patients with seizure disorders and used for intraoperative diagnosis of acute dysfunction in corticospinal axonal conduction

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brought about by mechanical trauma (traction, shearing, laceration, or compression) or vascular insufficiency.

The system can be connected to SpO2 and ETCO2 sensors to display the patient's oxygen saturation values as measured by pulse oximetry and CO2 values respectively throughout the procedure.

The acquired waveforms are displayed in cascaded format and measurement data may be displayed on the trend graph with waveform annotations (events). The acquired waveforms with the measurement data can be saved to a large capacity storage media. The data can be printed directly on paper, printed to portable document format (pdf), and/or archived to other locations.

The Neuromaster G1 MEE2000 System consists of at minimum a main unit (DC-200B), an amp unit (JB-232B), one breakout box (JB-210B), four stimulation pods [JS-201B(A), JS-202B (B), JS-203B (C), JS-204B (D)], and a computer (CC-201BK) with specific software. There are several standard and optional accessories such as cables, connectors, SpO2 probes, ETCO2 sensors, and various types of electrodes and leads.

A complete list of all modalities/software functions of the Neuromaster G1 MEE2000 System is given in Table 2.

# Table 2 MEE2000 Modalities/Software Functions

- Electrical Evoked Potentials ●
- o Somatosensory Evoked Potentials (SEP)
- Short-Latency Somatosensory Evoked Potential (SSEP) O
- Spinal cord evoked potentials (SCEP) (or ESCP: evoked spinal cord O potential)
- Electric Customizable о
- Auditory Evoked Potentials ●
- Auditory Brainstem Response (ABR) O
- Middle Latency Response (MLR) O
- Slow Vertex Response (SVR) O
- Electrocochleography (EcochG) O
- Auditory Customizable O
- Visual Evoked Potentials ●
- Pattern Reversal Visual Evoked Potential (PR-VEP) O
- O Goggle Visual Evoked Potential (LED goggle -VEP)
- Flash Visual Evoked Potential (Flash-VEP) O
- Electroretinography (ERG) O
- о Visual Customizable
- Electromyography (EMG) ●
- o Free-run EMG
- Electroencephalography (EEG) ●
- Electroencephalography (EEG) o
- Density Spectral Array (DSA) о
- Compressed Spectral Array (CSA) o
- Nerve Conduction
- o Motor Nerve Conduction studies (MCS)

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- Sensory Nerve Conduction studies (SCS) o
- Trend Monitoring
- Trend-ABR O
- Trend-SEP O
- Trend-VEP O
- Trend-DSA O
- o Trend-CSA
- Motor Evoked Potential (MEP) ●
- Transcranial Motor Evoked Potential (TcMEP) o
- o Cortical Motor Evoked Potential (CoMEP)
- Remote Monitoring ●

# Indications for Use

The Neuromaster G1 MEE 2000 Neural Function Measuring System is intended to monitor, record, and display the bioelectric signals produced by sensory and motor pathways in the operating room, critical care, and other areas where continuous monitoring is needed. The system measures and displays electric/auditory/visual evoked potential (EP), electroencephalography (EEG), and electromyography (EMG), skin temperature of distal portion of extremities, SpO2, and ETCO2 to provide health care professionals with information to help assess a patient's neurological status. The system is used as a nerve stimulator for surgical procedures and brain mapping during treatment of patients with seizure disorders and used for the intraoperative diagnosis of acute dysfunction in corticospinal axonal conduction brought about by mechanical trauma (traction, shearing, laceration, or compression) or vascular insufficiency.

· EEG - The device may also measure and record the electrical activities of the patient's brain obtained by placing two or more electrodes on the head (EEG).

· EP-Electrical/ Auditory/ Visual - Continuous and/or periodic measurements of evoked potential activities are displayed and stored. The device applies an electrical stimulus to a patient through commercially available skin electrodes for the purpose of measuring the evoked response. The photic stimulator is used to generate and display a shifting pattern or to apply a brief light stimulus to a patient's eye and the auditory stimulator produces a sound stimulus for use in evoked response measurements or electroencephalogram activation.

· Free Run EMG - The Free Run EMG function identifies spontaneous EMG activity of nerves by continually displaying a live stream waveform of any mechanically induced myotome contractions.

· CoMEP - Cortical stimulation techniques for cortical mapping are used at "Low Output" for placement of electrodes during surgical procedures and for brain mapping during treatment of patients with seizure disorders.

· TcMEP - Transcranial electrical stimulation techniques for motor evoked potentials (TcMEP) are used at "TcMEP Output" for the intraoperative diagnosis of acute dysfunction in corticospinal axonal conduction brought about by mechanical trauma (traction, shearing, laceration, or compression) or vascular insufficiency.

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· Nerve conduction study - The device is intended to measure and display nerve conduction time by applying a stimulus to a patient's peripheral nerve. This device includes the stimulator and the electronic processing equipment for measuring and displaying the nerve conduction time.

• SpO2 - When the SpO2 adapter and finger and toe probe for SpO2 measurement are used. oxygen saturation information is automatically measured and displayed.

· EtCO2 - When the CO2 adapter and sensor for EtCO2 measurement are used, endtidal carbon dioxide of respiratory gas information is automatically measured and displayed.

• Skin temperature - When the skin temperature sensor for skin temperature measurement is used, skin temperature information is automatically measured and displayed.

· Remote reader – The remote reader function provides real time remote access to the system for a monitoring physician outside of the operating room.

The device is intended for use by medical personnel within a hospital, laboratory, clinic or nursing home setting or outside of a medical facility under direct supervision of a medical professional.

The device is available for use on any patient as determined by the medical professional including adults and children of all ages.

## Comparison to Predicate Devices

Table 3 contains a comparison of the Neuromaster G1 MEE2000 System to its main predicate device, the Neuromaster MEE1000 System and additional "reference" predicates to support certain aspects in this comparison. Table 4, Table 5, Table 6, Table 7, and Table 8 have been included to completely describe the substantial equivalence comparison of the detailed functional aspects of the Neuromaster G1 MEE2000 to its predicates. Table 9 contains a detailed comparison of the new Neuromaster G1 MEE2000 NCS Electrode to the predicate electrode to support the physical, patient contact and material aspects in this comparison.

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| Characteristic | Neuromaster G1 MEE2000 System<br>(this submission) | Neuromaster MEE1000 System<br>Nihon Kohden<br>(K051178) | Comparison and additional<br>reference predicates |
|---------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | The Neuromaster G1 MEE 2000 Neural<br>Function Measuring System is intended to<br>monitor, record, and display the bioelectric<br>signals produced by sensory and motor<br>pathways in the operating room, critical<br>care, and other areas where continuous<br>monitoring is needed. The system measures<br>and displays electric/auditory/visual evoked<br>potential (EP), electroencephalography<br>(EEG), and electromyography (EMG), skin<br>temperature of distal portion of extremities,<br>SpO2, and ETCO2 to provide health care<br>professionals with information to help assess<br>a patient's neurological status. The system<br>is used as a nerve stimulator for surgical<br>procedures and brain mapping during<br>treatment of patients with seizure disorders<br>and used for the intraoperative diagnosis of<br>acute dysfunction in corticospinal axonal<br>conduction brought about by mechanical<br>trauma (traction, shearing, laceration, or<br>compression) or vascular insufficiency.<br>• EEG - The device may also measure and<br>record the electrical activities of the patient's<br>brain obtained by placing two or more<br>electrodes on the head (EEG).<br>• EP-Electrical/ Auditory/ Visual -<br>Continuous and/or periodic measurements of<br>evoked potential activities are displayed and<br>stored. The device applies an electrical<br>stimulus to a patient through commercially | Nihon Kohden's model number MEE-1000 is<br>intended for medical purposes to measure,<br>monitor, record and display the bioelectric<br>signals produced by muscles (EMG), to<br>stimulate peripheral nerves and to monitor,<br>record and display the electrical activities<br>produced by nerves to aid clinicians in the<br>diagnosis and prognosis of neuromuscular<br>disease. The device monitors<br>electric/auditory/visual evoked potential,<br>EEG and EMG. The device is also intended<br>to measure and display nerve conduction<br>time by applying a stimulus to a patient's<br>peripheral nerve. This device includes the<br>stimulator and the electronic processing<br>equipment for measuring and displaying the<br>nerve conduction time. The device may use<br>electrical stimulus, visual stimulus, or sound<br>stimulus for use in evoked response<br>measurements (EP). Continuous and/or<br>periodic measurements of evoked potential<br>activities are displayed and stored. The<br>device applies an electrical stimulus to a<br>patient thru commercially available skin<br>electrodes for the purpose of measuring the<br>evoked response. The photic stimulator is<br>used to generate and display a shifting<br>pattern or to apply a brief light stimulus to a<br>patient's eye and the auditory stimulator<br>produces a sound stimulus for use in evoked<br>response measurements or<br>electroencephalogram activation. The device | The subject device has the same<br>intended use as the main predicate<br>device. The indications for use for the<br>MEE2000 include two aspects that are<br>covered by additional reference<br>predicate devices: One is the inclusion<br>of SpO2 and EtCO2 measurements<br>which is also included in the Eclipse<br>Neurological Workstation by Axon<br>(K050798). The second is the<br>inclusion of nerve stimulator at low<br>output for surgical procedures and<br>braining mapping during treatment of<br>patients with seizure disorders and at<br>high output to be used for the<br>intraoperative diagnosis of acute<br>dysfunction in corticospinal axonal<br>conduction brought about by<br>mechanical trauma (traction, shearing,<br>laceration, or compression) or vascular<br>insufficiency. This second indication<br>for use is covered by another reference<br>predicate, MS120BK Electric<br>Stimulator (K1110410). The<br>MS120BK Electric stimulator was<br>cleared to connect to the MEE1000<br>through its amplifier. In the subject<br>device the capability is included. |
| Characteristic | Neuromaster G1 MEE2000 System<br>(this submission) | Neuromaster MEE1000 System<br>Nihon Kohden<br>(K051178) | Comparison and additional<br>reference predicates |
| Indications for Use,<br>con't | available skin electrodes for the purpose of<br>measuring the evoked response. The photic<br>stimulator is used to generate and display a<br>shifting pattern or to apply a brief light<br>stimulus to a patient's eye and the auditory<br>stimulator produces a sound stimulus for use<br>in evoked response measurements or<br>electroencephalogram activation.<br>• Free Run EMG - The Free Run EMG<br>function identifies spontaneous EMG<br>activity of nerves by continually displaying<br>a live stream waveform of any mechanically<br>induced myotome contractions.<br>• CoMEP - Cortical stimulation techniques<br>for cortical mapping are used at "Low<br>Output" for placement of electrodes during<br>surgical procedures and for brain mapping<br>during treatment of patients with seizure<br>disorders.<br>• TcMEP - Transcranial electrical<br>stimulation techniques for motor evoked<br>potentials (TcMEP) are used at "TcMEP<br>Output" for the intraoperative diagnosis of<br>acute dysfunction in corticospinal axonal<br>conduction brought about by mechanical<br>trauma (traction, shearing, laceration, or<br>compression) or vascular insufficiency."<br>• Nerve conduction study - The device is<br>intended to measure and display nerve<br>conduction time by applying a stimulus to a<br>patient's peripheral nerve. This device<br>includes the stimulator and the electronic | may be used to determine autonomic<br>responses as psychological indicators by<br>measuring the electrical resistance of the skin<br>and the tissue path between two electrodes<br>applied to the skin. The device may also<br>measure and record the electrical activities of<br>the patient's brain obtained by placing two or<br>more electrodes on the head (EEG). The<br>acquired waveforms are displayed in<br>cascaded format and measurement data may<br>be displayed on the trendgraph with<br>waveforms annotations (events). The<br>acquired waveforms with the measurement<br>data can be saved in a large capacity storage<br>media. The device is intended for use by<br>medical personnel within a hospital,<br>laboratory, clinic or nursing home setting or<br>outside of a medical facility under direct<br>supervision of a medical professional. The<br>device is available for use on any patient as<br>determined by the medical professional<br>including adults and children. | See above |
| Characteristic | Neuromaster G1 MEE2000 System<br>(this submission) | Neuromaster MEE1000 System<br>Nihon Kohden<br>(K051178) | Comparison and additional<br>reference predicates |
| Indications for Use,<br>con't | processing equipment for measuring and<br>displaying the nerve conduction time.<br>• SpO2 - When the SpO2 adapter and<br>finger and toe probe for SpO2 measurement<br>are used, oxygen saturation information is<br>automatically measured and displayed.<br>• EtCO2 - When the CO2 adapter and<br>sensor for EtCO2 measurement are used,<br>end-tidal carbon dioxide of respiratory gas<br>information is automatically measured and<br>displayed.<br>• Skin temperature - When the skin<br>temperature sensor for skin temperature<br>measurement is used, skin temperature<br>information is automatically measured and<br>displayed.<br>• Remote reader – The remote reader<br>function provides real time remote access to<br>the system for a monitoring physician<br>outside of the operating room.<br>The system is intended for use by medical<br>personnel within a hospital, laboratory,<br>clinic or nursing home setting or outside of a<br>medical facility under direct supervision of a<br>medical professional.<br>The system is available for use on any<br>patient as determined by the medical<br>professional including adults and children of<br>all ages. | See above | See above |
| Characteristic | Neuromaster G1 MEE2000 System<br>(this submission) | Neuromaster MEE1000 System<br>Nihon Kohden<br>(K051178) | Comparison and additional<br>reference predicates |
| Warnings/<br>Contraindications | Items related to off label use or misuse.<br>Items related to design and indicated use<br>limitations such as, not for use in the<br>presence of flammable anesthetics or in<br>conjunction with defibrillation equipment<br>Warnings regarding use of paralyzing agents<br>and surgical severing of nerves<br>Contraindication regarding use of TcMEP | Items related to off label use or misuse. Items<br>related to design and indicated use<br>limitations such as, not for use in the<br>presence of flammable anesthetics or in<br>conjunction with defibrillation equipment | Most warnings and precautions are the<br>same as MEE1000<br>Contraindication& Warnings same as<br>Eclipse (K050798) |
| Intended Use Patient<br>Population | The system is available for use on any<br>patient as determined by the medical<br>professional including adults and children of<br>all ages. | The device is available for use on any patient<br>as determined by the medical professional<br>including adults and children | No difference |
| General System<br>Approach | Computer based equipment with dedicated<br>hardware peripherals/components | Computer based equipment with dedicated<br>hardware peripherals/components | The specific peripherals/components<br>are more compact for customer<br>convenience |
| Input Boxes (Breakout<br>boxes) | 1, 2, 3 or 4 input boxes | 1, 2 or 3 input boxes | Number of input pins is 1 higher,<br>MEB-2300A (K12097). |
| Stimulation Pod | 1, 2, 3 or 4 within low-level | 1, 2, 3 or 4 and 1 or 2 at low-level | Number of units are reduced (The<br>MEE2000 has 4 stimulation pods<br>which are for both normal stimulation<br>and low level stimulation whereas the<br>MEE1000 has 4 stimulation pods for<br>normal stimulation and 2 other<br>stimulation pods for low level<br>stimulation.) |
| Characteristic | Neuromaster G1 MEE2000 System<br>(this submission) | Neuromaster MEE1000 System<br>Nihon Kohden<br>(K051178) | Comparison and additional<br>reference predicates…